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0-2 years
Not Disclosed
10 Oct. 10, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title:

CRA II (Clinical Research Associate II)

Location:

Taiwan – Client Site

Job ID:

25102411


Company Overview:

Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. The company leverages clinical, medical affairs, and commercial insights to drive outcomes.

Highlights:

  • Patient- and client-centric clinical development model

  • Agile, collaborative, and innovative work environment

  • 29,000 employees across 110 countries

  • Inclusive Total Self culture promoting authenticity and belonging


Job Summary:

CRA II is responsible for overseeing and ensuring the integrity of clinical research studies through site qualification, initiation, monitoring, and close-out activities. The role applies both on-site and remote monitoring strategies and collaborates with site teams to enhance quality and compliance with ICH-GCP, GPP, and other applicable regulations.


Key Responsibilities:

  • Perform site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remote)

  • Evaluate site performance and staff, providing recommendations and action plans for site-specific issues

  • Verify informed consent processes and protect patient confidentiality

  • Assess factors affecting patient safety and data integrity, including protocol deviations and pharmacovigilance issues

  • Conduct Source Document Review and verify CRF data accuracy and completeness

  • Apply query resolution techniques and guide site staff to close queries within timelines

  • Ensure compliance with electronic data capture requirements

  • Manage investigational product (IP) inventory, storage, and reconciliation; verify protocol-compliant dispensing

  • Review Investigator Site File (ISF) and reconcile with Trial Master File (TMF)

  • Document activities via trip reports, follow-up letters, and communication logs

  • Support patient recruitment, retention, and awareness initiatives

  • Track project scope, budgets, timelines, and site-level communications to meet objectives

  • Act as liaison with study site personnel or Central Monitoring Associate

  • Participate in Investigator Meetings, sponsor meetings, and global clinical project staff meetings

  • Support audit readiness and follow-up actions

  • For Real World Late Phase studies (SMA II):

    • Provide site support throughout the study lifecycle

    • Conduct chart abstraction and data collection

    • Collaborate with sponsor affiliates, medical liaisons, and local staff

    • Train junior staff and identify out-of-scope activities

    • Suggest potential sites based on local knowledge of treatment patterns and HCP networks


Qualifications:

  • Bachelor’s degree or RN in a related field, or equivalent combination of education and experience

  • Knowledge of Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements

  • Strong computer skills and ability to adopt new technologies

  • Excellent communication, presentation, and interpersonal skills

  • Ability to travel up to 75% regularly


Impact and Contribution:

  • Ensures the integrity and quality of clinical research studies using centralized monitoring, risk-based techniques, and compliance checks

  • Contributes to the design, implementation, and delivery of processes, tools, and SOPs to enhance trial quality

  • Collaborates with site teams to improve monitoring efficiency and trial success

  • Acts as a key individual contributor, potentially managing small components of projects or junior staff

  • Plays a critical role in patient safety, data quality, and overall clinical trial outcomes


Job Category:

Clinical Operations / Clinical Monitoring / CRA